CRYO-HIT™ is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissue.

Device Description

CRYO-HIT™ is a cryosurgical system that consists of:

1, a structural enclosure (The CRYO-HIT™ system is housed in a rack assembly mounted on four cater wheels for ease of transport),
1. a power control panel,
1. a computer and control assembly,
4, a gas supply system: Argon (cooling) and Helium (thawing) gas reservoirs,
1. a gas distribution system (valve assembly ),
1. Accessories: cryoprobes (named galil-eo probes), temperature sensors and a remote control unit.
  The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe ports available in each model (3-probe, 5-probe, 7-probes and 8-probe configurations) and the number of temperature sensor ports ( to meet the needs of different customers).
  The probes used for the 3-probe, 7-probes and 8-probe configurations are exactly the same.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (CRYO-HIT™ System) and as such does not contain a study section with acceptance criteria and a description of a study to prove the device meets those criteria. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on establishing the substantial equivalence of the CRYO-HIT™ system to existing cryosurgical devices based on intended use, technology, and operating principles.

Summary

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Galil Medical Proprietary Information

K980913

Section 9

510(k) Summary of Safety and Effectiveness

10008 JUL

ring

Galil Medical - CRYO-HIT™ System 510(k) Number K_

For Release Upon Request Only *

Company Name:

Galil Medical Ltd.

Contact Person:

Shaike Shatzberger, President and CEO Elisabeth Sadka, Regulatory manager

Telephone: +972-4-959 10 80 Fax: +972-4-959 10 77

Trade Proprietary Name:

CRYO-HITTM.

Classification Name:

CRYOSURGICAL UNIT

Classification:

GEH

Predicate Devices:

CRYOcare - ENDOcare. CMS AccuProbe System.

297

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Indication for Use:

Device Description:

CRYO-HIT™ is a cryosurgical system that consists of:

1, a structural enclosure (The CRYO-HIT™ system is housed in a rack assembly mounted on four cater wheels for ease of transport),
1. a power control panel,
1. a computer and control assembly,
4, a gas supply system: Argon (cooling) and Helium (thawing) gas reservoirs,
1. a gas distribution system (valve assembly ),
1. Accessories: cryoprobes (named galil-eo probes), temperature sensors and a remote control unit.

The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe ports available in each model (3-probe, 5-probe, 7-probes and 8-probe configurations) and the number of temperature sensor ports ( to meet the needs of different customers).

The probes used for the 3-probe, 7-probes and 8-probe configurations are exactly the same.

Technological Characteristics and Substantial Equivalence:

The CRYO-HIT™ System has the same intended use, and very similar principle of operation and technological characteristic as ENDOcare and CMS Accuprobe System, thus the CRYO-HITM System is substantial equivalent to these legally marketed predicate devices.

298

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUM SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10008 . IUL

Galil Medical Limited c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteen Street, N.W. Washington, DC 20004

Re: K980913 Trade Name: Cryo-Hit Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Regulatory Class: II Product Code: GEI Dated: June 11, 1998 Received: June 11, 1998

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market these devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

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Page 2 - Mr. Jonathan Kahan

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Salix M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1998 JUL

Galil Medical Proprietary Information

Section 9

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

CRYO-HIT™ System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRHA Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproducti e, Abdominal, Ean Nose and Throat, and Radiological Devices

510(k) Number K980913

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.